Draining PLN and Synovial Inflammation in RA Knee Joints Pre and Post Anti-TNF or B Cell Depletion Therapy
Stopped early
Conditions studied: Rheumatoid Arthritis
In brief
The purpose of this study is to examine the effect of anti-TNF therapy on rheumatoid arthritis using magnetic resonance imaging (MRI) and ultrasound imaging. Anti-TNF therapies include a group of medications such as Enbrel, Remicade and Humira that affect your body's inflammatory response. These medications are routinely prescribed for the treatment of rheumatoid arthritis.
Key facts
- Study ID
- NCT01083563
- Run by
- University of Rochester
- People needed
- 7
- Starts
- 2009-07-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed, IRB-approved, written informed consent
- Subjects can be of either gender but must be more than 18 years old.
- Subjects must fulfill the disease activity criteria for RA and a DAS28 will be assessed at baseline and at 2 months after rituximab therapy.
- Aim A - Eligible subjects must meet criteria for RA and have an inadequate response to MTX defined as DAS28 >5.1. They must have been on a steady dose of MTX (between 15 and 20 mg /week for a minimum of 8 weeks). Subjects must have evidence of knee synovitis on exam to enter the study.
- Aim B - Subjects must have demonstrated a response to a TNF antagonist as evidenced by a DAS score <2.8 or <4 tender and swollen joints. Flare will be defined as a DAS 28 >5.1 of more than 8 swollen and tender joints. Subjects must have evidence of knee synovitis to enter the study. Subjects will be off etanercept, infliximab or adalimumab for 4 weeks before starting BCDT. All subjects must also be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine) for 8 weeks before entry into the study.
You may not qualify if…
- Patients will be excluded for medical or other reasons at the discretion of the investigators. The reasons for the exclusion must be recorded, e.g. risk of non-compliance, vulnerability, medically unstable, etc.
- Active systemic disorders or inflammatory conditions (i.e., chronic infection with hepatitis B, hepatitis C or HIV) other than the conditions being studied.
- Patients with a plasma creatinine > 1.5 mg/dl
- Aim B - Subjects with an allergy to corticosteroids will be excluded from the study.
- Anyone answering yes to the following questions will be excluded:
- Do you have a history of:
- Cardiac (Heart) pacemaker or defibrillator?
- Cardiac (Heart) valve replacement or prosthesis?
- Aneurysm clips from brain surgery?
- Ear prosthesis (cochlear or stapedial implant)? (hearing aids?)
- Neurostimulator?
- Biostimulator?
- Any type of pumps in or on your body?
- Shrapnel, gunshot wound, BB pellet?
- Metallic penile prosthesis?
- Metallic blood vessel filter or stent?
- Orthopedic prosthesis?
- Have you ever had an injury involving metal fragments in your eye?
- Have you ever had neurosurgery (brain or skull surgery)?
- Note: Subjects treated with rituximab will not be excluded from study based on their immunosuppressive drugs but use of these agents will be recorded and discussed in the analysis.
Where it is running
- University of Rochester — Rochester, New York, United States
Full record on ClinicalTrials.gov
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